New York, May 22, 2026, 11:10 EDT
Larimar Therapeutics stock moved lower in late-morning trading Friday as investors watched for a June regulatory update on its top Friedreich’s ataxia treatment. LRMR was down 3.36% to $3.45 at 11:02 a.m. EDT while the market was still open, according to StockAnalysis data. StockAnalysis
Larimar is aiming to kick off a rolling Biologics License Application for nomlabofusp in June. A BLA is the FDA’s main filing for companies looking to bring a biologic drug to the U.S. market. Accelerated approval means the application could get cleared using a surrogate marker rather than waiting for full results. Larimar Therapeutics, Inc.
Larimar Therapeutics, Inc. plans to send in the nonclinical and clinical modules first, then file the CMC module in the second half. The company also sees topline readout from its open-label study coming this quarter. First patient dosing in a global confirmatory Phase 3 is targeted for mid-2026. Larimar Therapeutics, Inc.
Larimar CEO Carole Ben-Maimon said the company is “coming down the homestretch” on its BLA filing as it waits for FDA feedback. Larimar wants a Type B meeting before it starts the rolling submission, the company said. Larimar Therapeutics, Inc.
Larimar said it closed March with $200.4 million in cash, cash equivalents and marketable securities, and sees that lasting into the second quarter of 2027. The company posted a net loss of $29.6 million, or 31 cents per share for the first quarter, versus a loss of $29.3 million in the same period last year. Larimar Therapeutics, Inc.
Wall Street’s view is mostly upbeat, but the stock keeps moving around. According to StockAnalysis, nine analysts have a Strong Buy call. Laura Chico at Wedbush dropped her target to $12 from $13 on May 18 but kept a Buy. StockAnalysis
Larimar shareholders signed off on increasing the authorized share count to 215 million from 115 million at the annual meeting, according to a governance filing. The move gives the board flexibility on future equity sales. No new stock was issued as part of this vote. SEC
The field is thin but still has a few names. Biogen owns Skyclarys after the Reata buy, and the FDA cleared it as the first therapy for Friedreich’s ataxia. PTC Therapeutics saw the FDA turn down vatiquinone last year, showing the agency hasn’t backed every FA drug. U.S. Food and Drug Administration
Larimar’s drug approach isn’t the same as Skyclarys. Nomlabofusp aims to supply frataxin, the protein people with Friedreich’s ataxia lack. Larimar says the FDA has backed the idea that skin frataxin could act as a “reasonably likely” surrogate endpoint. In other words, it might serve as an indirect indicator of benefit for accelerated approval. Larimar Therapeutics, Inc.
The path for Larimar could still change. In its latest quarterly filing, Larimar warned the FDA might not sign off on the rolling BLA approach, and said safety data will just be reviewed later. The company also pointed to manufacturing scale-up and future trial results as possible hurdles that could slow things down or make approval harder. With the bigger share authorization, Larimar could face more dilution if it needs to raise cash. SEC
LRMR is showing the uncertainty for now. Shares dropped around 2.9% in the past five sessions and 8.8% this year as of 11:09 a.m. EDT, according to MarketScreener. The stock trades below analyst target prices. Marketscreener
